Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial

Abstract

Background Diabetic kidney disease (DKD) is one of the main complications of type 2 diabetes mellitus (T2DM). DKD is a known risk factor for end-stage renal disease, cardiovascular disease, and all-cause death. Effective intervention for early-stage DKD is vital to slowing down the progression of kidney disease and improve prognoses. Mobile health (mHealth) is reportedly effective in supporting patients’ self-care and improving glycemic control, but the impact of mHealth on DKD has yet to be shown. Objective The purpose of this study is to evaluate the efficacy of standard therapy with the addition of a self-management support system, DialBetesPlus, in patients with DKD and microalbuminuria. Methods This study is a prospective, randomized, open-label, multicenter clinical trial. The target population consists of 160 patients diagnosed with T2DM accompanied by microalbuminuria. We randomly assigned the patients to 2 groups—the intervention group using DialBetesPlus in addition to conventional therapy and the control group using conventional therapy alone. DialBetesPlus is a smartphone application that supports patients’ self-management of T2DM. The study period was 12 months, with a follow-up survey at 18 months. The primary outcome was a change in albuminuria levels at 12 months. Secondary outcomes included changes in physical parameters, blood test results (glycemic control, renal function, and lipid metabolism), lifestyle habits, self-management scores, medication therapy, and quality of life. Results The study was approved in April 2018. We began recruiting patients in July 2018 and completed recruiting in August 2019. The final 18-month follow-up was conducted in March 2021. We recruited 159 patients and randomly allocated 70 into the intervention group and 61 into the control group, with 28 exclusions due to withdrawal of consent, refusal to continue, or ineligibility. The first results are expected to be available in 2021. Conclusions This is the first randomized controlled trial assessing the efficacy of mHealth on early-stage DKD. We expect that albuminuria levels will decrease significantly in the intervention group due to improved glycemic control with ameliorated self-care behaviors. Trial Registration UMIN-CTR UMIN000033261; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037924 International Registered Report Identifier (IRRID) DERR1-10.2196/31061

Lifestyle interventions delivered by eHealth in chronic kidney disease: A scoping review

“…There was 15 non-randomised studies (one study was reported twice [25,26]) (this included eight uncontrolled before-after studies, four non-RCTs, two cohort studies and one cross-sectional study), four process evaluations (plus a further evaluation [28] of an included RCT [27]) and two developmental studies [29,30] (Table 1). Lastly, there were eight protocol publications of RCTs in progress [31][32][33][34][35][36][37][38] (S3 Table ). The eHealth component for 22 of these primarily involved mobile applications, seven involved web-based platforms, six involved SMS messages, six included videoconferencing or online videos, five included VREx, three included wearables, one was web-based messaging, and the remaining two involved a personal digital assistant (PDA), and tablet-based application (Tables 2 and S3).…”

Effect of Step Count Measurement on Glycemic Control: Secondary Analysis of a Randomized Controlled Trial

“…The intervention was discontinued at month 12. All methods and participants' eligibility criteria are described in further detail in the study protocol [12]. The Research Ethics Committee of the Graduate School of Medicine, the University of Tokyo approved the study protocol and informed consent form.…”

What are the roles of eHealth literacy and empowerment in self‐management in an eHealth care context? A cross‐sectional study

“…They mainly cater to patients' needs related to healthcare activities, such as monitoring, uploading and analysing health status, navigation, tracking, emergency call function, notification, communicating and setting the goals of health tasks (Donald et al, 2018; Saghaee et al, 2020). Remote healthcare providers can understand the dynamic changes in patients' health and provide individualised services (Kawai et al, 2021; Markossian et al, 2021). Especially during the COVID‐19 pandemic, health technologies provide services mainly in follow‐up visits for treatment plans, self‐management training, consultations and caregiver support, thereby allowing patients to prevent COVID‐19 infection and continue regular disease management (Bitar & Alismail, 2021; Wang et al, 2021).…”